BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    High Flow Insufflation Unit (UHI-4)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    IPM Wound Gel Bio, IPM Derm Gel Bio

    FDA 510(k)
    FDA Unclassified ·Unknown

    RELIEVA SINUS BALLOON DILATION CATHETER

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    SL 1 INTRODUCER UNK

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·March 10, 2011

    RESPONSE EP CATHETER UNK

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DRF·March 10, 2011

    TRANSSEPTAL NEEDLE, BRK SERIES

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·March 10, 2011

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 11, 2014

    LIBERTÉ (TM)

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code MAF·September 12, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTN·July 23, 2013

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025